The following data is part of a premarket notification filed by Fudakang Industrial Co., Ltd with the FDA for Fudakang Bluetooth Digital Thermometer (model: Bt-a41cn-bt).
| Device ID | K160308 |
| 510k Number | K160308 |
| Device Name: | Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Fudakang Industrial Co., Ltd No. 8 Yinghe Road, Yuanjiangyuan Management Zone Changping Town Dongguan, CN 523560 |
| Contact | Bob Yu |
| Correspondent | Field Fu Shenzhen Joyantech Consulting Co., Ltd. 2032#, International Mayor Communication Center Shizhou Zhong Road 55#, Na Shenzhen, CN 518100 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-04 |
| Decision Date | 2016-07-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10810038630196 | K160308 | 000 |
| 10810038631063 | K160308 | 000 |
| 16955647600063 | K160308 | 000 |
| 10810038631865 | K160308 | 000 |
| 10810038633777 | K160308 | 000 |
| 10810038633708 | K160308 | 000 |